FDA recall D-0116-2017

Product

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

Reason for recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Distribution

US & Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-09-13

Report date

2016-11-09

Termination date

2018-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brampton, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2017